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Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200)

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Avelumab
Docetaxel
Sponsored by
EMD Serono Research & Development Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Avelumab, MSB0010718C, Non-Small Cell Lung Cancer, Anti-PD-L1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Signed written informed consent before any trial related procedure
  • Male or female participants aged greater than or equal to (>=) 18 years
  • Availability of a formalin-fixed, paraffin-embedded block containing tumor tissue or 7 unstained tumor slides suitable for PD-L1 expression assessment
  • Tumor determined to be evaluable for PD-L1 expression per the evaluation of a central laboratory
  • Participants with histologically confirmed Stage IIIb/IV or recurrent NSCLC who have experienced disease progression

  • Participants must have progressed after an acceptable therapy defined as follows:

    1. Participants must have progressed during or after a minimum of 2 cycles of 1 course of a platinum based combination therapy administered for the treatment of a metastatic disease. A history of continuation (use of a non platinum agent from initial combination) or switch (use of a different agent) maintenance therapy is permitted provided there was no progression after the initial combination. A switch of agents during treatment for the management of toxicities is also permitted provided there was no progression after the initial combination OR
    2. Participants must have progressed within 6 months of completion of a platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for locally advanced disease
  • Participants with non-squamous cell NSCLC of unknown epidermal growth factor receptor (EGFR) mutation status will require testing (local laboratory, or central laboratory if local testing is not available). Participants with a tumor that harbors an activating EGFR mutation will not be eligible
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry
  • Estimated life expectancy of more than 12 weeks
  • Adequate hematological function defined by White Blood Cell (WBC) count >= 2.5 × 10^9/L with absolute neutrophil count (ANC) >= 1.5 × 10^9/L, lymphocyte count >=0.5 × 10^9/L, platelet count >= 100 × 10^9/L, and hemoglobin >= 9 gram per deciliter (g/dL) (may have been transfused)
  • Adequate hepatic function defined by a total bilirubin level less than or equal to (<=) 1.5 × the upper limit of normal (ULN) range and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels <= 2.5 × ULN for all participants
  • Adequate renal function defined by an estimated creatinine clearance > 30 milliliter per minute (mL/min) according to the Cockcroft-Gault formula (or local institutional standard method).

Other protocol defined inclusion criteria could apply

Exclusion criteria

  • In the United States only, participants with a squamous cell histology will be excluded
  • Systemic anticancer therapy administered after disease progression during or following a platinum based combination
  • Participants with non-squamous cell NSCLC whose disease harbors EGFR mutation(s) and/or anaplastic lymphoma kinase (ALK) rearrangement will not be eligible for this trial. Participants of unknown ALK and/or EGFR mutation status will require testing at screening (local laboratory, or central laboratory if local testing is not available)
  • Prior therapy with any antibody/drug targeting T cell coregulatory proteins (immune checkpoints) such as PD-1, PD L1, or cytotoxic T lymphocyte antigen-4 (CTLA-4).
  • Concurrent anticancer treatment
  • Major surgery for any reason, except diagnostic biopsy, within 4 weeks of randomization and/or if the participant has not fully recovered from the surgery within 4 weeks of randomization
  • Participants receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the trial treatment.

  • All participants with brain metastases, except those meeting the following criteria:

    1. Brain metastases have been treated locally, and
    2. No ongoing neurological symptoms that are related to the brain localization of the disease

  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:

    1. Participants with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible
    2. Participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses less than or equal to (<=)10 milligram (mg) or equivalent prednisone per day
    3. Administration of steroids through a route known to result in a minimal systemic exposure are acceptable
  • Previous or ongoing administration of systemic steroids for the management of an acute allergic phenomenon is acceptable as long as it is anticipated that the administration of steroids will be completed in 14 days, or that the daily dose after 14 days will be <=10 mg per day of equivalent prednisone

Other protocol defined exclusion criteria could apply

Sites / Locations

  • University of Alabama
  • Mayo Clinic
  • Pacific Cancer Medical Center, Inc.
  • Healing Hands Oncology and Medical Care
  • Sutter Gould Medical Foundation
  • Sharp Memorial Hospital
  • Lynn Cancer Institute Center
  • University Cancer Institute
  • Holy Cross Hospital Inc.
  • Florida Cancer Specialists-Broadway
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Northeast Georgia Cancer Care, LLC
  • Metairie Oncologist, LLC
  • Henry Ford Health System
  • Hematology Oncology Associates of Rockland
  • Novant Health Oncology Specialists
  • Oncology Hematology Care
  • Signal Point Clinical Research Center
  • Mercy Clinic Oklahoma Communities, Inc.
  • Abington Memorial Hospital
  • Penn State Univ. Milton S. Hershey Medical Center
  • Center for Biomedical Research, LLC
  • SCRI - Tennessee Oncology
  • The Center for Cancer and Blood Disorders
  • University of Texas Health Science Center at Tyler
  • MultiCare Health System
  • Hospital Italiano Regional del Sur
  • Clínica Universitaria Privada Reina Fabiola
  • Centro de Oncologia e Investigacion Buenos Aires
  • Instituto Medico Especializado Alexander Fleming
  • CEMIC
  • Instituto DAMIC Fundacion Rusculleda
  • Centro Oncologico Riojano Integral (Cori)
  • Centro Oncologico de Parana
  • Hospital Universitario Austral
  • Instituto Gamma
  • Sanatorio Parque S.A.
  • Instituto de Oncología de Rosario
  • Centro Medico San Roque S.R.L.
  • Ballarat Base Hospital
  • Box Hill Hospital
  • Coffs Harbour Base Hospital
  • Lyell McEwin Hospital
  • Greenslopes Private Hospital
  • Lismore Base Hospital
  • Royal Melbourne Hospital
  • St John of God Hospital
  • Princess Alexandra Hospital
  • UZ Antwerpen
  • Grand Hôpital de Charleroi
  • UZ Leuven
  • Centre Hospitalier de l'Ardenne
  • C. H. U. Sart Tilman
  • AZ Delta
  • Cenantron - Centro Avançado de Tratamento Oncológico S/C Ltda
  • CEPON - Centro de Pesquisas Oncológicas de Santa Catarina
  • Hospital de Caridade de Ijuí
  • Clínica de Neoplasias Litoral Ltda.
  • CMiP - Centro Mineiro de Pesquisa
  • Hospital Bruno Born
  • Liga Norte-Rio-Grandense Contra o Câncer
  • Oncosinos - Clínica de Oncologia - Hospital Regina
  • CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo
  • Hospital Mãe de Deus
  • Hospital São Lucas da PUCRS
  • COI - Clínicas Oncológicas Integradas
  • CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
  • IOS - Instituto de Oncologia de Sorocaba "Dr. Gilson Delgado"
  • Fundação Faculdade Regional de Medicina de São José do Rio Preto
  • ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
  • UMHAT 'Dr. Georgi Stranski', EAD
  • Complex Oncological Center - Plovdiv, EOOD
  • MHAT "Serdika", EOOD
  • MHAT 'Tokuda Hospital Sofia', AD
  • Shato, Ead
  • MHAT 'Sv. Marina', EAD
  • Instituto de Terapias Oncologicas Providencia
  • FALP - Fundación Arturo López Pérez
  • CIEC - Centro Internacional de Estudios Clínicos
  • Instituto Clinico Oncologico del Sur (ICOS)
  • Centro de Investigaciones Clinicas Viña del Mar
  • Hospital Clinico Viña del Mar
  • Fundacion Cardioinfantil Instituto de Cardiologia
  • Instituto Nacional de Cancerologia E.S.E.
  • Clinica Colsanitas S.A. sede Clinica Universitaria Colombia
  • Administradora Country S.A.
  • Fundación Valle del Lilí
  • Centro Medico Imbanaco
  • Hemato Oncologos S.A.
  • Instituto de Cancerologia S.A.
  • Hospital Pablo Tobón Uribe
  • IPS IMAT- Instituto Medico de Alta Tecnologia - Oncomedica S.A.
  • General Hospital Dubrovnik
  • General Hospital Zadar
  • Clinical Hospital Centar "Sestre Milosrdnice"
  • University Clinic for Pulmonary Diseases
  • Masarykuv onkologicky ustav
  • Nemocnice Novy Jicin a.s.
  • Multiscan s.r.o.
  • Vseobecna fakultni nemocnice V Praze
  • Thomayerova nemocnice
  • Herlev Hospital
  • Odense Universitetshospital
  • ICO - Site Paul Papin
  • CHU Besançon - Hôpital Jean Minjoz
  • Clinique Victor Hugo - Centre Jean Bernard
  • Hôpital Nord - AP-HM Marseille#
  • Centre Catherine de Sienne
  • Centre Antoine Lacassagne
  • Groupe Hospitalier Sud - Hôpital Haut-Lévêque
  • CHU Poitiers - Hôpital la Milétrie
  • ICO - Site René Gauducheau
  • CHU Strasbourg - Nouvel Hôpital Civil
  • CHU de Toulouse - Hôpital Larrey
  • Semmelweis Egyetem AOK
  • Uzsoki Utcai Korhaz
  • Petz Aladar Megyei Oktato Korhaz
  • Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz
  • Tudogyogyintezet Torokbalint
  • Soroka Medical Center
  • Assaf Harofeh Medical Center
  • Rambam Health Care Campus
  • The Lady Davis Carmel Medical Center
  • Hadassah University Hospital - Ein Kerem
  • Sapir Medical Center, Meir Hospital
  • Rabin Medical Center-Beilinson Campus
  • Chaim Sheba Medical Center
  • Tel Aviv Sourasky Medical Center
  • Azienda Ospedaliera Istituti Ospitalieri di Cremona
  • Ospedale Mater Salutis
  • Ospedale Versilia
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • IEO Istituto Europeo di Oncologia
  • Seconda Università degli Studi di Napoli
  • Azienda Ospedaliero Universitaria Pisana
  • Università Campus Bio-Medico di Roma
  • Istituto Nazionale Tumori Regina Elena IRCCS
  • Policlinico Universitario Agostino Gemelli
  • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
  • A.O.U. Senese Policlinico Santa Maria alle Scotte
  • Azienda Ospedaliera Ospedale Treviglio-Caravaggio di Treviglio
  • National Cancer Center Hospital
  • NHO Kyushu Cancer Center
  • Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
  • Hiroshima City Hiroshima Citizens Hospital
  • National Cancer Center Hospital East
  • Saitama Cancer Center
  • Institute of Biomedical Research and Innovation Hospital
  • Kobe City Hospital Organization Kobe City Medical Center General Hospital
  • Cancer Institute Hospital of JFCR
  • Kurume University Hospital
  • Miyagi Cancer Center
  • Aichi Cancer Center Hospital
  • Osaka City General Hospital
  • Osaka Medical Center for Cancer and Cardiovascular Diseases
  • Kinki University Hospital
  • Kitasato University Hospital
  • NHO Hokkaido Cancer Center
  • Hokkaido University Hospital
  • Tokyo Medical University Hospital
  • Toyama University Hospital
  • Wakayama Medical University Hospital
  • Yokohama Municipal Citizen's Hospital
  • Kanagawa Cancer Center
  • Chungbuk National University Hospital
  • Chonnam National University Hwasun Hospital
  • Gachon University Gil Medical Center
  • Seoul National University Bundang Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Korea University Guro Hospital
  • Korea University Anam Hospital
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • The Catholic University of Korea, St. Vincent's Hospital
  • Phylasis Clinicas Research S de RL de CV
  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
  • Fundacion Rodolfo Padilla Padilla, A.C.
  • Health Pharma Professional Research S.A. de C.V.
  • Winsett Rethman S.A. de C.V.
  • Centro de Investigacion Clinica Chapultepec S.A. de C.V.
  • Oaxaca Site Management Organization S.C.
  • Centro Oncologico Estatal ISSEMyM
  • Clinica Monte Carmelo
  • Hospital Nacional Almanzor Aguinaga Asenjo
  • Hospital Nacional Adolfo Guevara Velasco
  • Clinica San Borja
  • Hospital Nacional Guillermo Almenara Irigoyen
  • Clínica Ricardo Palma
  • Instituto Nacional de Enfermedades Neoplásicas
  • Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
  • Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej
  • Samodzielny Publiczny Szpital Kliniczny nr 5 SUM
  • Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
  • KO-MED Centra Kliniczne Lublin II
  • SSZZOZ im. Dr Teodora Dunina w Rudce
  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
  • Spitalul Judetean de Urgenta Alba Iulia
  • Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare
  • Policlinica de Diagnostic Rapid SRL
  • Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea
  • Spital Lotus SRL
  • S.C Oncocenter Oncologie Clinica S.R.L
  • SHI "Republican Clinical Oncological Dispensary of HM RT"
  • SHBI Moscow Clinical Scientific Center of Department of Healthcare of Moscow
  • FSBHI Clinical research institute of phthisiopulmonology
  • Pavlov First Saint Petersburg State Medical University
  • St. Petersburg SHI "City Clinical Oncology Dispensary"
  • FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
  • Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov
  • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
  • Ustredna vojenska nemocnica SNP Ruzomberok- Fakultna nemocnica
  • Fakultna nemocnica Trnava
  • GVI Cape Gate Oncology Centre
  • GVI Rondebosch Oncology Centre
  • GVI Langenhoven Drive Oncology Centre
  • University of Pretoria Oncology Department
  • Mary Potter Oncology Centre
  • Hospital General Universitario de Alicante
  • ICO Badalona - Hospital Germans Trias i Pujol
  • Hospital Universitari Quiron Dexeus
  • Hospital Universitari Vall d'Hebron
  • Hospital Clinic i Provincial de Barcelona
  • ICO l´Hospitalet - Hospital Duran i Reynals
  • Hospital Universitario Materno-Infantil de Canarias
  • Hospital Universitario Ramon y Cajal
  • Centro Integral Oncologico Clara Campal
  • Hospital Clinico Universitario Virgen de la Victoria
  • Hospital de Mataro
  • Complejo Hospitalario Universitario de Santiago
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario Virgen del Rocio
  • Hospital Universitari i Politecnic La Fe
  • Kantonsspital Graubuenden
  • Taichung Veterans General Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Tri-Service General Hospital
  • Chang Gung Memorial Hospital, Linkou
  • Hacettepe University Medical Faculty
  • Baskent University Ankara Hospital
  • Ankara University Medical Faculty
  • Trakya University Medical Faculty
  • Bezmi Alem Foundation University Medical Faculty Hospital
  • Istanbul University Cerrahpasa Medical Faculty
  • Fatih Universitesi Tip Fakultesi
  • Marmara University Pendik Research and Training Center
  • Ege University Medical Faculty
  • Dokuz Eylul University Medicine Faculty
  • Konya Necmettin Erbakan University Meram Faculty of Medicine
  • Royal Bournemouth General Hospital
  • Bristol Haematology & Oncology Centre
  • Royal Devon and Exeter Hospital (Wonford)
  • Beatson West of Scotland Cancer Centre
  • St James's University Hospital
  • University College London Hospital
  • Derriford Hospital
  • Mount Vernon Hospital
  • The Clatterbridge Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Avelumab

Docetaxel

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival (OS) Time in Programmed Death Ligand 1 (PD-L1) + Full Analysis Set Population (FAS)
The OS time was defined as the time from randomization to the date of death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.

Secondary Outcome Measures

Overall Survival (OS) Time in Full Analysis Set Population
The OS time was defined as the time from randomization to the date of death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.
Progression-Free Survival (PFS) Time in PD-L1+ Full Analysis Set Population
PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. PFS was measured using Kaplan-Meier (KM) estimates.
Progression-Free Survival (PFS) Time in Full Analysis Set Population
PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. PFS was measured using Kaplan-Meier (KM) estimates.
Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by an Independent Endpoint Review Committee (IERC) in Full Analysis Set Population
Confirmed BOR was determined according to RECIST v1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.
Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population
Confirmed BOR was determined according to RECIST v1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.
Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in Full Analysis Set Population
Percentage of participants with objective response (CR plus PR) according to RECIST v1.1 was reported. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.
Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population
Percentage of participants with objective response (CR plus PR) according to RECIST v1.1 was reported. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score at End of Treatment (EOT)
The EQ-5D-5L health outcome questionnaire was a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L defined health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items were combined to generate health profiles. These profiles were converted to a continuous single index score. The lowest possible score was -0.59 (unable to walk, unable to self-care, unable to do usual activities, extreme pain or discomfort, extreme anxiety or depression) and the highest was 1.00 (no problems in all 5 dimensions).
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Visual Analogue Scale (VAS) at End of Treatment (EOT)
EQ-5D-5L was comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses were used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 was the worst health you can imagine and 100 was the best health you can imagine.
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT)
EORTC QLQ-C30 was a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). The EORTC QLQ-C30 GHS/QoL score ranged from 0 to 100; High score indicated better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT)
EORTC QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The EORTC QLQ-LC13 module generated one multiple-item score assessing dyspnea and a series of single item scores assessing coughing, hemoptysis, sore mouth, dysphagia, neuropathy, alopecia, pain in chest, pain in arms or shoulder and pain in other parts. Score range: 0 (no burden of symptom domain or single symptom item) to 100 (highest burden of symptoms for symptom domains and single items).
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Drug Related Treatment Emergent Adverse Events and Treatment Emergent Adverse Events Leading to Death
An Adverse event (AE) was defined as any unfavorable and unintended sign (including clinically significant abnormal laboratory, vital signs and 12-lead Electrocardiogram findings), symptom, or disease temporally associated with the use of study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent events were the events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity
Treatment Emergent Adverse Events were graded as per National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03 (NCI-CTCAE v 4.03). Grade 3 refers to severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care and Activity of daily living (ADL), Grade 4 refers to Life-threatening consequences; where urgent intervention indicated, Grade 5 refers to the death related to adverse event.
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Worst Post-baseline Score
ECOG performance status measured to assess participant's performance status on a scale of 0 to 5, where 0 = Fully active, able to carry on all pre-disease activities without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; 3 = Capable of only limited self-care, confined to bed/chair for more than 50 percent of waking hours; 4 = Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5 = dead. The participants with missing worst post baseline score were also reported. ECOG performance status was reported in terms of number of participants with Baseline value vs. worst post-baseline value (i.e. highest score) combination.
Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab
Serum samples were analyzed by a validated electrochemiluminesce immunoassay to detect the presence of antidrug antibodies (ADA). Samples that screened positive were subsequently tested in a confirmatory assay were tested for neutralizing antibodies (nAb). Number of participants with ADA or nAb positive results for Avelumab were reported.

Full Information

First Posted
February 27, 2015
Last Updated
July 20, 2020
Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02395172
Brief Title
Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200)
Official Title
A Phase III Open-Label, Multicenter Trial of Avelumab (MSB0010718C) Versus Docetaxel in Subjects With Non-Small Cell Lung Cancer That Has Progressed After a Platinum-Containing Doublet
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 24, 2015 (Actual)
Primary Completion Date
November 22, 2017 (Actual)
Study Completion Date
December 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main purpose of this study was to demonstrate superiority with regard to overall survival of avelumab versus docetaxel in participants with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC) after failure of a platinum-based doublet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
Avelumab, MSB0010718C, Non-Small Cell Lung Cancer, Anti-PD-L1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
792 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Avelumab
Arm Type
Experimental
Arm Title
Docetaxel
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Avelumab
Intervention Description
Participants received 10 milligrams per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.
Primary Outcome Measure Information:
Title
Overall Survival (OS) Time in Programmed Death Ligand 1 (PD-L1) + Full Analysis Set Population (FAS)
Description
The OS time was defined as the time from randomization to the date of death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.
Time Frame
Time from date of randomization up to 1420 days
Secondary Outcome Measure Information:
Title
Overall Survival (OS) Time in Full Analysis Set Population
Description
The OS time was defined as the time from randomization to the date of death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.
Time Frame
Time from date of randomization up to 1420 days
Title
Progression-Free Survival (PFS) Time in PD-L1+ Full Analysis Set Population
Description
PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. PFS was measured using Kaplan-Meier (KM) estimates.
Time Frame
Time from date of randomization up to 907 days
Title
Progression-Free Survival (PFS) Time in Full Analysis Set Population
Description
PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. PFS was measured using Kaplan-Meier (KM) estimates.
Time Frame
Time from date of randomization up to 907 days
Title
Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by an Independent Endpoint Review Committee (IERC) in Full Analysis Set Population
Description
Confirmed BOR was determined according to RECIST v1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.
Time Frame
Time from date of randomization up to 907 days
Title
Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population
Description
Confirmed BOR was determined according to RECIST v1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.
Time Frame
Time from date of randomization up to 907 days
Title
Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in Full Analysis Set Population
Description
Percentage of participants with objective response (CR plus PR) according to RECIST v1.1 was reported. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.
Time Frame
Time from date of randomization up to 907 days
Title
Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population
Description
Percentage of participants with objective response (CR plus PR) according to RECIST v1.1 was reported. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.
Time Frame
Time from date of randomization up to 907 days
Title
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score at End of Treatment (EOT)
Description
The EQ-5D-5L health outcome questionnaire was a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L defined health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items were combined to generate health profiles. These profiles were converted to a continuous single index score. The lowest possible score was -0.59 (unable to walk, unable to self-care, unable to do usual activities, extreme pain or discomfort, extreme anxiety or depression) and the highest was 1.00 (no problems in all 5 dimensions).
Time Frame
Baseline, End of treatment visit (up to Week 124)
Title
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Visual Analogue Scale (VAS) at End of Treatment (EOT)
Description
EQ-5D-5L was comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses were used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 was the worst health you can imagine and 100 was the best health you can imagine.
Time Frame
Baseline, End of treatment visit (up to Week 124)
Title
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT)
Description
EORTC QLQ-C30 was a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). The EORTC QLQ-C30 GHS/QoL score ranged from 0 to 100; High score indicated better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.
Time Frame
Baseline, End of treatment visit (up to Week 124)
Title
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT)
Description
EORTC QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The EORTC QLQ-LC13 module generated one multiple-item score assessing dyspnea and a series of single item scores assessing coughing, hemoptysis, sore mouth, dysphagia, neuropathy, alopecia, pain in chest, pain in arms or shoulder and pain in other parts. Score range: 0 (no burden of symptom domain or single symptom item) to 100 (highest burden of symptoms for symptom domains and single items).
Time Frame
Baseline, End of treatment visit (up to Week 124)
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Drug Related Treatment Emergent Adverse Events and Treatment Emergent Adverse Events Leading to Death
Description
An Adverse event (AE) was defined as any unfavorable and unintended sign (including clinically significant abnormal laboratory, vital signs and 12-lead Electrocardiogram findings), symptom, or disease temporally associated with the use of study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent events were the events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs.
Time Frame
Time from date of randomization up to 1420 days
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity
Description
Treatment Emergent Adverse Events were graded as per National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03 (NCI-CTCAE v 4.03). Grade 3 refers to severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care and Activity of daily living (ADL), Grade 4 refers to Life-threatening consequences; where urgent intervention indicated, Grade 5 refers to the death related to adverse event.
Time Frame
Time from date of randomization up to 1420 days
Title
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Worst Post-baseline Score
Description
ECOG performance status measured to assess participant's performance status on a scale of 0 to 5, where 0 = Fully active, able to carry on all pre-disease activities without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; 3 = Capable of only limited self-care, confined to bed/chair for more than 50 percent of waking hours; 4 = Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5 = dead. The participants with missing worst post baseline score were also reported. ECOG performance status was reported in terms of number of participants with Baseline value vs. worst post-baseline value (i.e. highest score) combination.
Time Frame
Time from date of randomization up to 1420 days
Title
Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab
Description
Serum samples were analyzed by a validated electrochemiluminesce immunoassay to detect the presence of antidrug antibodies (ADA). Samples that screened positive were subsequently tested in a confirmatory assay were tested for neutralizing antibodies (nAb). Number of participants with ADA or nAb positive results for Avelumab were reported.
Time Frame
Time from date of randomization up to 1420 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Signed written informed consent before any trial related procedure Male or female participants aged greater than or equal to (>=) 18 years Availability of a formalin-fixed, paraffin-embedded block containing tumor tissue or 7 unstained tumor slides suitable for PD-L1 expression assessment Tumor determined to be evaluable for PD-L1 expression per the evaluation of a central laboratory Participants with histologically confirmed Stage IIIb/IV or recurrent NSCLC who have experienced disease progression Participants must have progressed after an acceptable therapy defined as follows: Participants must have progressed during or after a minimum of 2 cycles of 1 course of a platinum based combination therapy administered for the treatment of a metastatic disease. A history of continuation (use of a non platinum agent from initial combination) or switch (use of a different agent) maintenance therapy is permitted provided there was no progression after the initial combination. A switch of agents during treatment for the management of toxicities is also permitted provided there was no progression after the initial combination OR Participants must have progressed within 6 months of completion of a platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for locally advanced disease Participants with non-squamous cell NSCLC of unknown epidermal growth factor receptor (EGFR) mutation status will require testing (local laboratory, or central laboratory if local testing is not available). Participants with a tumor that harbors an activating EGFR mutation will not be eligible Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry Estimated life expectancy of more than 12 weeks Adequate hematological function defined by White Blood Cell (WBC) count >= 2.5 × 10^9/L with absolute neutrophil count (ANC) >= 1.5 × 10^9/L, lymphocyte count >=0.5 × 10^9/L, platelet count >= 100 × 10^9/L, and hemoglobin >= 9 gram per deciliter (g/dL) (may have been transfused) Adequate hepatic function defined by a total bilirubin level less than or equal to (<=) 1.5 × the upper limit of normal (ULN) range and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels <= 2.5 × ULN for all participants Adequate renal function defined by an estimated creatinine clearance > 30 milliliter per minute (mL/min) according to the Cockcroft-Gault formula (or local institutional standard method). Other protocol defined inclusion criteria could apply Exclusion criteria In the United States only, participants with a squamous cell histology will be excluded Systemic anticancer therapy administered after disease progression during or following a platinum based combination Participants with non-squamous cell NSCLC whose disease harbors EGFR mutation(s) and/or anaplastic lymphoma kinase (ALK) rearrangement will not be eligible for this trial. Participants of unknown ALK and/or EGFR mutation status will require testing at screening (local laboratory, or central laboratory if local testing is not available) Prior therapy with any antibody/drug targeting T cell coregulatory proteins (immune checkpoints) such as PD-1, PD L1, or cytotoxic T lymphocyte antigen-4 (CTLA-4). Concurrent anticancer treatment Major surgery for any reason, except diagnostic biopsy, within 4 weeks of randomization and/or if the participant has not fully recovered from the surgery within 4 weeks of randomization Participants receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the trial treatment. All participants with brain metastases, except those meeting the following criteria: Brain metastases have been treated locally, and No ongoing neurological symptoms that are related to the brain localization of the disease Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent: Participants with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible Participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses less than or equal to (<=)10 milligram (mg) or equivalent prednisone per day Administration of steroids through a route known to result in a minimal systemic exposure are acceptable Previous or ongoing administration of systemic steroids for the management of an acute allergic phenomenon is acceptable as long as it is anticipated that the administration of steroids will be completed in 14 days, or that the daily dose after 14 days will be <=10 mg per day of equivalent prednisone Other protocol defined exclusion criteria could apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35401
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale , Phoenix
State/Province
Arizona
ZIP/Postal Code
85259-5499
Country
United States
Facility Name
Pacific Cancer Medical Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Healing Hands Oncology and Medical Care
City
Lawndale
State/Province
California
ZIP/Postal Code
90260
Country
United States
Facility Name
Sutter Gould Medical Foundation
City
Modesto
State/Province
California
ZIP/Postal Code
95355
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Lynn Cancer Institute Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
University Cancer Institute
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Holy Cross Hospital Inc.
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Florida Cancer Specialists-Broadway
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Florida Cancer Specialists
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Florida Cancer Specialists
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Northeast Georgia Cancer Care, LLC
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Metairie Oncologist, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Hematology Oncology Associates of Rockland
City
Nyack
State/Province
New York
ZIP/Postal Code
10960
Country
United States
Facility Name
Novant Health Oncology Specialists
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Oncology Hematology Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Signal Point Clinical Research Center
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Mercy Clinic Oklahoma Communities, Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120-9309
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Penn State Univ. Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Center for Biomedical Research, LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
SCRI - Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
The Center for Cancer and Blood Disorders
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
University of Texas Health Science Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Facility Name
MultiCare Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Hospital Italiano Regional del Sur
City
Bahia Blanca
ZIP/Postal Code
B8001HXM
Country
Argentina
Facility Name
Clínica Universitaria Privada Reina Fabiola
City
Barrio General Paz
ZIP/Postal Code
X5004FHP
Country
Argentina
Facility Name
Centro de Oncologia e Investigacion Buenos Aires
City
Berazategui
ZIP/Postal Code
B1880BBF
Country
Argentina
Facility Name
Instituto Medico Especializado Alexander Fleming
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
CEMIC
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
Instituto DAMIC Fundacion Rusculleda
City
Cordoba
ZIP/Postal Code
X5003DCE
Country
Argentina
Facility Name
Centro Oncologico Riojano Integral (Cori)
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Facility Name
Centro Oncologico de Parana
City
Parana
ZIP/Postal Code
3100
Country
Argentina
Facility Name
Hospital Universitario Austral
City
Pilar
ZIP/Postal Code
B1629ODT
Country
Argentina
Facility Name
Instituto Gamma
City
Rosario
ZIP/Postal Code
S2000CRF
Country
Argentina
Facility Name
Sanatorio Parque S.A.
City
Rosario
ZIP/Postal Code
S2000DSV
Country
Argentina
Facility Name
Instituto de Oncología de Rosario
City
Rosario
ZIP/Postal Code
S2000KZE
Country
Argentina
Facility Name
Centro Medico San Roque S.R.L.
City
San Miguel de Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Ballarat Base Hospital
City
Ballarat
ZIP/Postal Code
3350
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
Facility Name
Coffs Harbour Base Hospital
City
Coffs Harbour
ZIP/Postal Code
2450
Country
Australia
Facility Name
Lyell McEwin Hospital
City
Elizabeth Vale
ZIP/Postal Code
5112
Country
Australia
Facility Name
Greenslopes Private Hospital
City
Greenslopes
ZIP/Postal Code
4120
Country
Australia
Facility Name
Lismore Base Hospital
City
Lismore
ZIP/Postal Code
2480
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
ZIP/Postal Code
3050
Country
Australia
Facility Name
St John of God Hospital
City
Subiaco
ZIP/Postal Code
6008
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Grand Hôpital de Charleroi
City
Gilly
ZIP/Postal Code
6060
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier de l'Ardenne
City
Libramont
ZIP/Postal Code
6800
Country
Belgium
Facility Name
C. H. U. Sart Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Cenantron - Centro Avançado de Tratamento Oncológico S/C Ltda
City
Belo Horizonte
ZIP/Postal Code
30110-921
Country
Brazil
Facility Name
CEPON - Centro de Pesquisas Oncológicas de Santa Catarina
City
Florianópolis
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Hospital de Caridade de Ijuí
City
Ijuí
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Clínica de Neoplasias Litoral Ltda.
City
Itajaí
ZIP/Postal Code
88310-110
Country
Brazil
Facility Name
CMiP - Centro Mineiro de Pesquisa
City
Juiz de Fora
ZIP/Postal Code
36010-570
Country
Brazil
Facility Name
Hospital Bruno Born
City
Lajeado
ZIP/Postal Code
95900-000
Country
Brazil
Facility Name
Liga Norte-Rio-Grandense Contra o Câncer
City
Natal
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
Oncosinos - Clínica de Oncologia - Hospital Regina
City
Novo Hamburgo
ZIP/Postal Code
93510-250
Country
Brazil
Facility Name
CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo
City
Passo Fundo
ZIP/Postal Code
99010-260
Country
Brazil
Facility Name
Hospital Mãe de Deus
City
Porto Alegre
ZIP/Postal Code
90110-270
Country
Brazil
Facility Name
Hospital São Lucas da PUCRS
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
COI - Clínicas Oncológicas Integradas
City
Rio de Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
City
Santo André
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
IOS - Instituto de Oncologia de Sorocaba "Dr. Gilson Delgado"
City
Sorocaba
ZIP/Postal Code
18030-075
Country
Brazil
Facility Name
Fundação Faculdade Regional de Medicina de São José do Rio Preto
City
São José do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
City
São Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
UMHAT 'Dr. Georgi Stranski', EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Complex Oncological Center - Plovdiv, EOOD
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
MHAT "Serdika", EOOD
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
Facility Name
MHAT 'Tokuda Hospital Sofia', AD
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Shato, Ead
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
MHAT 'Sv. Marina', EAD
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Instituto de Terapias Oncologicas Providencia
City
Santiago
ZIP/Postal Code
7500000
Country
Chile
Facility Name
FALP - Fundación Arturo López Pérez
City
Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
CIEC - Centro Internacional de Estudios Clínicos
City
Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Instituto Clinico Oncologico del Sur (ICOS)
City
Temuco
Country
Chile
Facility Name
Centro de Investigaciones Clinicas Viña del Mar
City
Viña del Mar
ZIP/Postal Code
2540364
Country
Chile
Facility Name
Hospital Clinico Viña del Mar
City
Viña del Mar
Country
Chile
Facility Name
Fundacion Cardioinfantil Instituto de Cardiologia
City
Bogota
ZIP/Postal Code
110131
Country
Colombia
Facility Name
Instituto Nacional de Cancerologia E.S.E.
City
Bogota
ZIP/Postal Code
111511
Country
Colombia
Facility Name
Clinica Colsanitas S.A. sede Clinica Universitaria Colombia
City
Bogota
Country
Colombia
Facility Name
Administradora Country S.A.
City
Bogotá
Country
Colombia
Facility Name
Fundación Valle del Lilí
City
Cali
ZIP/Postal Code
760032
Country
Colombia
Facility Name
Centro Medico Imbanaco
City
Cali
ZIP/Postal Code
760042
Country
Colombia
Facility Name
Hemato Oncologos S.A.
City
Cali
Country
Colombia
Facility Name
Instituto de Cancerologia S.A.
City
Medellin
Country
Colombia
Facility Name
Hospital Pablo Tobón Uribe
City
Medellín
ZIP/Postal Code
050034
Country
Colombia
Facility Name
IPS IMAT- Instituto Medico de Alta Tecnologia - Oncomedica S.A.
City
Monteria
Country
Colombia
Facility Name
General Hospital Dubrovnik
City
Dubrovnik
ZIP/Postal Code
20000
Country
Croatia
Facility Name
General Hospital Zadar
City
Zadar
ZIP/Postal Code
23000
Country
Croatia
Facility Name
Clinical Hospital Centar "Sestre Milosrdnice"
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Clinic for Pulmonary Diseases
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Masarykuv onkologicky ustav
City
Brno
ZIP/Postal Code
65653
Country
Czechia
Facility Name
Nemocnice Novy Jicin a.s.
City
Novy Jicin
ZIP/Postal Code
74101
Country
Czechia
Facility Name
Multiscan s.r.o.
City
Pardubice
ZIP/Postal Code
53203
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice V Praze
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Thomayerova nemocnice
City
Praha 4
ZIP/Postal Code
14059
Country
Czechia
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
ICO - Site Paul Papin
City
Angers Cedex 9
ZIP/Postal Code
49933
Country
France
Facility Name
CHU Besançon - Hôpital Jean Minjoz
City
Besancon Cedex
ZIP/Postal Code
25030
Country
France
Facility Name
Clinique Victor Hugo - Centre Jean Bernard
City
Le Mans Cedex 02
ZIP/Postal Code
72000
Country
France
Facility Name
Hôpital Nord - AP-HM Marseille#
City
Marseille cedex 20
ZIP/Postal Code
13915
Country
France
Facility Name
Centre Catherine de Sienne
City
Nantes
ZIP/Postal Code
44202
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice cedex 02
ZIP/Postal Code
06189
Country
France
Facility Name
Groupe Hospitalier Sud - Hôpital Haut-Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CHU Poitiers - Hôpital la Milétrie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
ICO - Site René Gauducheau
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
CHU Strasbourg - Nouvel Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
CHU de Toulouse - Hôpital Larrey
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Semmelweis Egyetem AOK
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Uzsoki Utcai Korhaz
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz
City
Györ
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Tudogyogyintezet Torokbalint
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Soroka Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Beer Yaakov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
The Lady Davis Carmel Medical Center
City
Haifa
ZIP/Postal Code
34361
Country
Israel
Facility Name
Hadassah University Hospital - Ein Kerem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Sapir Medical Center, Meir Hospital
City
Kfar-Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center-Beilinson Campus
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Azienda Ospedaliera Istituti Ospitalieri di Cremona
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
Ospedale Mater Salutis
City
Legnago (VR)
ZIP/Postal Code
37045
Country
Italy
Facility Name
Ospedale Versilia
City
Lido di Camaiore
ZIP/Postal Code
55043
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
IEO Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Seconda Università degli Studi di Napoli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Università Campus Bio-Medico di Roma
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Istituto Nazionale Tumori Regina Elena IRCCS
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
A.O.U. Senese Policlinico Santa Maria alle Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Azienda Ospedaliera Ospedale Treviglio-Caravaggio di Treviglio
City
Treviglio
ZIP/Postal Code
24047
Country
Italy
Facility Name
National Cancer Center Hospital
City
Chuo-ku
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
NHO Kyushu Cancer Center
City
Fukuoka-shi
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
City
Habikino-shi
ZIP/Postal Code
583-8588
Country
Japan
Facility Name
Hiroshima City Hiroshima Citizens Hospital
City
Hiroshima-shi
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa-shi
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Saitama Cancer Center
City
Kitaadachi-gun
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Institute of Biomedical Research and Innovation Hospital
City
Kobe-shi
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Kobe City Hospital Organization Kobe City Medical Center General Hospital
City
Kobe-shi
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Cancer Institute Hospital of JFCR
City
Koto-ku
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume-shi
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Miyagi Cancer Center
City
Natori-shi
ZIP/Postal Code
981-1293
Country
Japan
Facility Name
Aichi Cancer Center Hospital
City
Okazaki-shi
ZIP/Postal Code
444-0011
Country
Japan
Facility Name
Osaka City General Hospital
City
Osaka-shi
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Osaka Medical Center for Cancer and Cardiovascular Diseases
City
Osaka-shi
ZIP/Postal Code
537-8511
Country
Japan
Facility Name
Kinki University Hospital
City
Osakasayama-shi
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Kitasato University Hospital
City
Sagamihara-shi
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
NHO Hokkaido Cancer Center
City
Sapporo-shi
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo-shi
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Shinjuku-ku
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Toyama University Hospital
City
Toyama-shi
ZIP/Postal Code
930-0194
Country
Japan
Facility Name
Wakayama Medical University Hospital
City
Wakayama-shi
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Yokohama Municipal Citizen's Hospital
City
Yokohama-shi
ZIP/Postal Code
240-8555
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Yokohama-shi
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun-gun
ZIP/Postal Code
519-763
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, St. Vincent's Hospital
City
Suwon-si
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Phylasis Clinicas Research S de RL de CV
City
Cuautitlan Izcalli
ZIP/Postal Code
54769
Country
Mexico
Facility Name
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Fundacion Rodolfo Padilla Padilla, A.C.
City
Leon
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Health Pharma Professional Research S.A. de C.V.
City
Mexico
ZIP/Postal Code
03810
Country
Mexico
Facility Name
Winsett Rethman S.A. de C.V.
City
Monterrey
ZIP/Postal Code
64060
Country
Mexico
Facility Name
Centro de Investigacion Clinica Chapultepec S.A. de C.V.
City
Morelia
ZIP/Postal Code
58260
Country
Mexico
Facility Name
Oaxaca Site Management Organization S.C.
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Centro Oncologico Estatal ISSEMyM
City
Toluca
ZIP/Postal Code
50180
Country
Mexico
Facility Name
Clinica Monte Carmelo
City
Arequipa
ZIP/Postal Code
04000
Country
Peru
Facility Name
Hospital Nacional Almanzor Aguinaga Asenjo
City
Chiclayo
ZIP/Postal Code
14001
Country
Peru
Facility Name
Hospital Nacional Adolfo Guevara Velasco
City
Cusco
Country
Peru
Facility Name
Clinica San Borja
City
Lima
ZIP/Postal Code
15000
Country
Peru
Facility Name
Hospital Nacional Guillermo Almenara Irigoyen
City
Lima
ZIP/Postal Code
Lima 13
Country
Peru
Facility Name
Clínica Ricardo Palma
City
Lima
ZIP/Postal Code
LIMA 27
Country
Peru
Facility Name
Instituto Nacional de Enfermedades Neoplásicas
City
Lima
ZIP/Postal Code
LIMA 34
Country
Peru
Facility Name
Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
City
Brzozow
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej
City
Jelenia Gora
ZIP/Postal Code
58-506
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 5 SUM
City
Katowice
ZIP/Postal Code
40-514
Country
Poland
Facility Name
Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
City
Lodz
ZIP/Postal Code
90-242
Country
Poland
Facility Name
KO-MED Centra Kliniczne Lublin II
City
Lublin
ZIP/Postal Code
20-362
Country
Poland
Facility Name
SSZZOZ im. Dr Teodora Dunina w Rudce
City
Mrozy
ZIP/Postal Code
05-320
Country
Poland
Facility Name
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Spitalul Judetean de Urgenta Alba Iulia
City
Alba Iulia
ZIP/Postal Code
510077
Country
Romania
Facility Name
Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare
City
Baia Mare
ZIP/Postal Code
430031
Country
Romania
Facility Name
Policlinica de Diagnostic Rapid SRL
City
Brasov
ZIP/Postal Code
500152
Country
Romania
Facility Name
Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea
City
Oradea
ZIP/Postal Code
410469
Country
Romania
Facility Name
Spital Lotus SRL
City
Ploiesti
ZIP/Postal Code
100011
Country
Romania
Facility Name
S.C Oncocenter Oncologie Clinica S.R.L
City
Timisoara
ZIP/Postal Code
300210
Country
Romania
Facility Name
SHI "Republican Clinical Oncological Dispensary of HM RT"
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
SHBI Moscow Clinical Scientific Center of Department of Healthcare of Moscow
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
FSBHI Clinical research institute of phthisiopulmonology
City
Saint Petersburg
ZIP/Postal Code
191036
Country
Russian Federation
Facility Name
Pavlov First Saint Petersburg State Medical University
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
St. Petersburg SHI "City Clinical Oncology Dispensary"
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov
City
Bardejov
ZIP/Postal Code
08501
Country
Slovakia
Facility Name
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
City
Bratislava
ZIP/Postal Code
82606
Country
Slovakia
Facility Name
Ustredna vojenska nemocnica SNP Ruzomberok- Fakultna nemocnica
City
Ruzomberok
ZIP/Postal Code
03426
Country
Slovakia
Facility Name
Fakultna nemocnica Trnava
City
Trnava
ZIP/Postal Code
91708
Country
Slovakia
Facility Name
GVI Cape Gate Oncology Centre
City
Cape Town
ZIP/Postal Code
7570
Country
South Africa
Facility Name
GVI Rondebosch Oncology Centre
City
Cape town
ZIP/Postal Code
7700
Country
South Africa
Facility Name
GVI Langenhoven Drive Oncology Centre
City
Port Elizabeth
ZIP/Postal Code
6045
Country
South Africa
Facility Name
University of Pretoria Oncology Department
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Mary Potter Oncology Centre
City
Pretoria
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
ICO Badalona - Hospital Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitari Quiron Dexeus
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
ICO l´Hospitalet - Hospital Duran i Reynals
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Universitario Materno-Infantil de Canarias
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Centro Integral Oncologico Clara Campal
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital de Mataro
City
Mataro
ZIP/Postal Code
08304
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Kantonsspital Graubuenden
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Linkou
City
Taoyuan County
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Baskent University Ankara Hospital
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Ankara University Medical Faculty
City
Ankara
Country
Turkey
Facility Name
Trakya University Medical Faculty
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Bezmi Alem Foundation University Medical Faculty Hospital
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Fatih Universitesi Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34500
Country
Turkey
Facility Name
Marmara University Pendik Research and Training Center
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Facility Name
Ege University Medical Faculty
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Dokuz Eylul University Medicine Faculty
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Konya Necmettin Erbakan University Meram Faculty of Medicine
City
Konya
ZIP/Postal Code
42080
Country
Turkey
Facility Name
Royal Bournemouth General Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Bristol Haematology & Oncology Centre
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital (Wonford)
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 OYN
Country
United Kingdom
Facility Name
St James's University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8BQ
Country
United Kingdom
Facility Name
Mount Vernon Hospital
City
Stevenage
ZIP/Postal Code
SG1 4AB
Country
United Kingdom
Facility Name
The Clatterbridge Cancer Centre
City
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
Citations:
PubMed Identifier
35771392
Citation
Coon CD, Schlichting M, Zhang X. Interpreting Within-Patient Changes on the EORTC QLQ-C30 and EORTC QLQ-LC13. Patient. 2022 Nov;15(6):691-702. doi: 10.1007/s40271-022-00584-w. Epub 2022 Jun 30.
Results Reference
derived
PubMed Identifier
35144482
Citation
Hrinczenko B, Iannotti N, Goel S, Spigel D, Safran H, Taylor MH, Bennouna J, Wong DJ, Kelly K, Verschraegen C, Bajars M, Manitz J, Ruisi M, Gulley JL. Long-term avelumab in advanced non-small-cell lung cancer: summaries and post hoc analyses from JAVELIN Solid Tumor. Future Oncol. 2022 Apr;18(11):1333-1342. doi: 10.2217/fon-2021-0930. Epub 2022 Feb 11.
Results Reference
derived
PubMed Identifier
33636453
Citation
Park K, Ozguroglu M, Vansteenkiste J, Spigel D, Yang JC, Bajars M, Ruisi M, Manitz J, Barlesi F. Impact of subsequent immune checkpoint inhibitor treatment on overall survival with avelumab vs docetaxel in platinum-treated advanced NSCLC: Post hoc analyses from the phase 3 JAVELIN Lung 200 trial. Lung Cancer. 2021 Apr;154:92-98. doi: 10.1016/j.lungcan.2021.01.026. Epub 2021 Feb 6.
Results Reference
derived
PubMed Identifier
30262187
Citation
Barlesi F, Vansteenkiste J, Spigel D, Ishii H, Garassino M, de Marinis F, Ozguroglu M, Szczesna A, Polychronis A, Uslu R, Krzakowski M, Lee JS, Calabro L, Aren Frontera O, Ellers-Lenz B, Bajars M, Ruisi M, Park K. Avelumab versus docetaxel in patients with platinum-treated advanced non-small-cell lung cancer (JAVELIN Lung 200): an open-label, randomised, phase 3 study. Lancet Oncol. 2018 Nov;19(11):1468-1479. doi: 10.1016/S1470-2045(18)30673-9. Epub 2018 Sep 24. Erratum In: Lancet Oncol. 2018 Nov;19(11):e581.
Results Reference
derived
Links:
URL
http://clinicaltrials.emdgroup.com/en/trial-details/?id=EMR100070_004
Description
Trial Awareness and Transparency website
URL
http://medical.emdserono.com/en_US/home.html
Description
US Medical Information website, Medical Resources

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Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200)

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